PFV — System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Class III
FDA product code PFV covers "System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PFV
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.